Haughton Design transitions to ISO 13485: 2016

By 6 February 2018 News No Comments
Haughton Design achieves ISO 13485:2016 transition accreditation

We are pleased to announce that Haughton Design has successfully transitioned our management system to the latest international standards. Our new scope is:

ISO 9001: 2015 – The provision of product development and engineering design consultancy, including the management of verification and validation.

ISO 13485: 2016 – The provision of product development and engineering design consultancy for medical devices, including the management of verification and validation services.

We were audited way back in November, with our certificates arriving only last week, so it’s good to finally announce our update has been successful. It’s very comforting to know we operate to both international standards. However, experience shows our medical device and pharmaceutical clients, want even higher standards than an ISO 13485 certificate to ensure full compliance for their medical device development projects.

So, during the wait we have been working hard to optimise our medical device development system, specifically to meet the pharma industry’s needs.  The goal is to ensure pharma clients needing combination product work have full confidence of compliance when they submit HD derived projects to the FDA and MHRA. It’s involved a full gap analysis by a combination device, design control specialist. He has identified a number of areas we can bolster ready for a visit from our pharma client’s quality team.

It all means more work and dedication to ensure we meet our client’s needs. Providing the best service possible is more than an accreditation. It’s about understanding what makes life easier for customers and continuously improving our system to help them get their products out and on the market as efficiently as possible.

We will always keep moving forward and improving our offer, thank you very much to everyone involved in this transition and continuously developing our systems. It’s an ever-moving target but especially to Matt and Malcolm, well done, you nailed it again!